Evaluating Safety Reporting in Complementary and Alternative Medicine Trials
Author Information
Author(s): Lucy-Ann Turner, Kavita Singh, Chantelle Garritty, Alexander Tsertsvadze, Eric Manheimer, Susan L. Wieland, James Galipeau, David Moher
Primary Institution: Ottawa Hospital Research Institute
Hypothesis
The study aims to assess the quality of safety reporting in CAM randomized controlled trials and explore the influence of trial characteristics on this quality.
Conclusion
The evaluation showed that safety reporting in CAM trials is largely inadequate and requires improvement.
Supporting Evidence
- Only 21% of trials had adequate safety reporting.
- 69% of trials reported fewer words on safety than on author affiliations.
- 15% of trials reported no adverse events during the trial period.
Takeaway
This study looked at how well trials of alternative medicine reported safety information, and found that many trials didn't do a good job at it.
Methodology
The study surveyed safety reporting in RCTs published in 2009 across 15 CAM interventions, assessing the adequacy of reporting of adverse events.
Potential Biases
The study may be biased due to the exclusion of non-English trials and reliance on published data.
Limitations
The study only included trials published in English and may not represent all CAM interventions.
Participant Demographics
The trials included a mix of adult populations using various CAM interventions.
Statistical Information
P-Value
0.045
Confidence Interval
95% CI, 0.98 to 6.32
Statistical Significance
p=0.045
Digital Object Identifier (DOI)
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